Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Biomarkers of oxidative damage
研究概览
简要总结
The investigators hypothesise that measuring biomarkers of oxidative damage could better inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD subjects.
详细描述
Subjects with idiopathic PD will be recruited to a 10-week dose escalation study. Each dosage (400mg/day, 800mg/day, 1200/day and 2400mg/day) will be consumed daily for two weeks. Information on safety and fasting blood/urine samples will be collected. Primary endpoint is plasma F2-isoprostanes (adjusted for arachidonate) while secondary endpoint is the change in the total Unified Parkinson Disease Rating Scale (UPDRS) before and after treatment. Serum phospholipase A2 activities, plasma all trans-retinol, plasma total tocopherol (sum of α-, δ- and γ-tocopherol) and serum uric acid will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic Parkinson disease
- •age >21 years
- •able to provide written informed consent
排除标准
- •diabetes mellitus, stroke, cardiac and renal diseases and cigarette smoking
- •major psychiatric disorder or drug and/or alcohol abuse/dependence
- •regular use of antioxidants, dietary supplements, traditional Chinese remedies, non-steroidal anti-inflammatory drugs or immunosuppressive drugs
结局指标
主要结局
Biomarkers of oxidative damage
时间窗: 10 weeks
次要结局
- Total Unified Parkinson's Disease Rating Scale (UPDRS)(10 weeks)
研究者
Medicine
Associate Professor
National University Hospital, Singapore